The Indian pharma and biotechnology industries are extremely enthusiastic about automation and digital transformation to spur revenues and productivity. The sector is looking to invest as global regulators mandate need to adopt Internet of Things (IoT) and artificial intelligence (AI) to remain compliant, increase the speed of execution and ultimately deliver competitive advantage.
The sector is scouting for technology experts, devising digital operation strategy for a 3 to 5 year period. The intent is to make certain intra-operability, information transparency and decentralisation of decision making to spur real value and bottom line impact. The impact of IoT and Internet of People brings about labour efficiency by 20 per cent.
The Industry 4.0 is the current trend of automation and data exchange in manufacturing technologies. It includes cyber-physical systems, the IoT, cloud computing and cognitive computing. Referred to as the fourth industrial revolution, the way forward is increased use of automation using AI. Until now, it was human intelligence, now it is the age of seamless integration of technology for modular structured smart plants where cyber systems monitor physical processes.
It is manufacture of process optimisation, machine-to-machine communication and integrated systems that trace and track every move. There is seamless record keeping and traceability critical to ensure error-free inspections and stall 483s that Indian pharma has been facing because of lack of data integrity, stated SG Belapure, managing director, Zydus Hospira.
The current challenges for the industry are complex supply chain across geographies with ever-increasing stock keeping units (SKUs) and regulatory compliance. There is lack of integrated planning, pressure for efficient operations and complex product development as personalised or precision medicine takes the stage, he added.
It is reported that digital transformation is now an integral part of corporate strategy and it has been estimated that within five years, 80% of companies would have digitised at last some part of their value chain. Indeed, with the current $55 billion global digital health market expected to grow at 21.4% per year, it has been rightly said that the patient journey is ripe for digital disruption, stated Belapure, at the national symposium PharmaNext 2018 on Automation and Digital transformation of pharma and life sciences industry.
With the global regulatory scrutiny at the highest level for Indian pharma and biotechnology, the industry needs to ensure better quality, data integrity and data access in real-time which provides visibility of productivity. There is also continuous real-time monitoring. This new era prevents, deviation and predicted parameters can be rectified to gain regulatory approval.
Yet another factor is that to cater to development of precision or personalised medicine is that for the development of these drugs made with unique features leads to production in small batches, designed in specific dosage. Even the US FDA has an emerging technology wing which is extending related regulatory approvals for smart, flexible, precise and continuous manufacturing, he said.
In India, the pharma and biotech industries are taking baby steps but is confident to adopt Industry 4.0. This is because it offers predictive and prescriptive analysis of tasks that go into drug manufacture. It creates a paperless batch records and the shift from electronic conversion to automation is now seen to be way forward for the industry. There is significant cost reduction, productivity, availability, reliability and performance, said Belapure.